Pronunciation:

sak-i-TOOZ-ue-mab goe-vi-TEE-kan - hziy

Brand Names:

• Trodelvy

Dosage Forms:

• Powder for Solution

Warnings:

Severe or life-threatening neutropenia may occur. Withhold sacituzumab govitecan-hziy for absolute neutrophil count below 1500/mm(3) or neutropenic fever. Monitor blood cell counts periodically during treatment during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patient with febrile neutropenia without delay.Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold sacituzumab govitecan-hziy until resolved to less than or equal to Grade 1 and reduce subsequent doses .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Sacituzumab Govitecan

Uses of This Medicine:

Sacituzumab govitecan-hziy injection is used to treat triple-negative breast cancer that has spread (metastatic) or cannot be removed by surgery (unresectable locally advanced). It is given to patients who have received 2 or more cancer treatments, including at least 1 treatment for metastatic disease.

Sacituzumab govitecan-hziy injection is also used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread (metastatic) or cannot be removed by surgery (unresectable locally advanced) in patients who have received endocrine treatment and at least 2 treatments for metastatic disease.

Sacituzumab govitecan-hziy injection is also used to treat urothelial cancer (bladder cancer and cancer of the urinary tract) that has spread or cannot be removed by surgery in patients who have received other cancer medicines (eg, immunotherapy medicine, platinum-containing cancer medicine).

Sacituzumab govitecan-hziy belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sacituzumab govitecan-hziy injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sacituzumab govitecan-hziy injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Probenecid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection or
• Neutropenia (low white blood cells)—May decrease your body's ability to fight an infection.

• Liver disease, moderate or severe—Use of this medicine has not been studied in patients with condition.

• Reduced UGT1A1 activity (an enzyme problem)——May increase risk for more serious side effects.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 3 hours for the first dose, then 1 or 2 hours for the next doses. The injection is usually given once a week on Days 1 and 8 of a 21-day treatment cycle.

Sacituzumab govitecan-hziy often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

You may also receive extra fluids and other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent unwanted side effects from the injection.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving the medicine and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting the treatment. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious types of allergic reactions, including anaphylaxis and infusion reaction, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, chills, dizziness, fever, hives, hoarseness, itching, skin rash, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

Sacituzumab govitecan-hziy often causes diarrhea. Diarrhea can begin while you are receiving a dose of medicine or shortly afterward, or it may occur more than 24 hours later. Your doctor may give you medicine to treat diarrhea. Follow instructions carefully.

Talk with your doctor before receiving this medicine if you plan to have children. Some women who receive this medicine have become infertile (unable to have children).

Sacituzumab govitecan-hziy can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

black, tarry stools

bladder pain

bleeding of the gums

bloody or cloudy urine

blurred vision

bone pain

burning, itching, and pain in the hairy areas, pus at the root of hair

burning, tingling, numbness or pain in the hands, arms, feet, or legs

coma

confusion

cough

decreased urine output

depression

difficult or labored breathing with exertion

difficult, burning, or painful urination

dizziness

drowsiness

dry mouth

fainting

fast heartbeat

fever or chills

flushed, dry skin

fruit-like breath odor

hostility

increased hunger

increased thirst

increased urination

irregular heartbeat

irritability

lethargy

lightheadedness

loss of appetite

lower back or side pain

mood or mental changes

muscle pain, spasms, or twitching

pale skin

pinpoint red spots on the skin

rapid, shallow breathing

rapid weight gain

seizures

severe diarrhea

severe nausea and vomiting

sneezing

sore throat

stomach pain or tenderness

stuffy or runny nose

stupor

sweating

swelling

swelling of the face, ankles, or hands

tightness in the chest

trembling

ulcers, sores, or white spots in the mouth

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Chest pain

pain in the groin or legs, especially the calves

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

vision changes

Rare

Difficulty swallowing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste

constipation

cracked lips

hair loss

loss of taste

rash

swelling or inflammation of the mouth

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.